CellAegis Devices Inc.
CellAegis Announces First Patients Enrolled in U.S. SHIELD Pivotal Clinical Trial
The autoRIC® device automatically delivers remote ischemic conditioning ("RIC") to provide a non-invasive, cardio-protective therapy shown to reduce heart damage during heart attacks and certain cardiovascular procedures.
SHIELD is a 500 patient, multi-center, randomized, controlled single-blind clinical trial designed to evaluate the safety and effectiveness of the autoRIC® device to attenuate myocardial injury, as measured by the validated biomarker cardiac Troponin I ("cTnl") levels in patients undergoing elective percutaneous coronary intervention ("PCI"). Patients that are scheduled for either an elective PCI procedure, or a diagnostic catheterization procedure that may be followed with stenting, will be enrolled in the study across up to 15 research sites in the U.S. and Canada. The primary efficacy outcome of this trial is to show a statistically significant reduction in the prevalence of ischemia-reperfusion injury to the myocardium in patients using the autoRIC® device compared to patients using a placebo device. Patients will be exited from the study after completion of their 30-day post-procedure follow-up.
"We are pleased to start enrolling patients in this clinical trial," commented Roxana Mehran, MD, principal investigator for SHIELD, Professor of Medicine and Director of Interventional Cardiovascular Research and Clinical Trials at the Zena and Michael A. Weiner Cardiovascular Institute at Mount Sinai School of Medicine. "While there have been tremendous advancements in cardiac care over the past several years, there is no question that significant unmet medical need remains. We believe this trial has been designed to clearly demonstrate whether the autoRIC® can reduce heart damage during PCI. This study will answer the question of whether the autoRIC® device; which is easy to use and implement, will have clinical utility in this patient population."
The autoRIC® device is approved by Health Canada and in Europe, where it is being used in multiple large investigator-sponsored trials to further assess effectiveness in reducing adverse events after a heart attack. A positive SHIELD study will be used to support CellAegis's premarket submission to the U.S. Food and Drug Administration (FDA) for US commercialization of the autoRIC® device.
"There are approximately 1 million elective PCI procedures performed annually in the US, in patients with ischemic heart disease and elevations of troponin resulting from the procedure, that have been shown to result in poorer clinical outcomes," said Rocky Ganske, Chief Executive Officer, CellAegis. "Enrollment of the first patients in this U.S. pivotal clinical trial represents an important step forward in the autoRIC® clinical development program. Our current expectations are to complete the study in the third quarter of 2018."
RIC is a noninvasive therapeutic that uses four cycles of limb occlusion and reperfusion to protect the myocardium against ischemia-reperfusion injury. RIC is a promising adjunctive treatment to PCI in the prevention of ischemic-reperfusion injury and minimization of postinfarction heart failure in ST-elevation myocardial infarction ("STEMI") patients. Previous proof-of-concept clinical studies using RIC before or during a major ischemic event have demonstrated improvements in surrogate markers of ischemia, such as increased myocardial salvage and reduced infarct size, in a variety of clinical scenarios including acute STEMI, elective PCI, and coronary artery bypass grafting surgery. Furthermore, in patients with STEMI, RIC before PCI has been shown to reduce the incidence of contrast-induced acute kidney injury and has prevented acute kidney injury in patients undergoing cardiopulmonary bypass-assisted cardiac surgery.
The autoRIC® device is designed to provide RIC to adult patients over 18 years of age undergoing cardiothoracic surgery, interventional cardiothoracic procedures or patients with evolving myocardial infarction. The technology is intended for use in hospital and ambulance settings as directed by healthcare professionals. The autoRIC® device is CE Marked, and Health Canada approved, and is currently limited to investigational use in the United States.
About CellAegis Devices
CellAegis Devices, headquartered in Toronto, Canada, is the world leader in automated remote ischemic conditioning. The company has patented and developed the non-invasive autoRIC® device, which delivers RIC therapy to patients with acute and chronic cardiovascular conditions. The autoRIC® device has CE Mark and Health Canada approvals for treatment during heart attacks, cardiothoracic or surgical procedures. Investigator sponsored clinical research studies for chronic conditions such as heart failure and stroke are also underway. The autoRIC® device was developed from the clinical work of clinicians and researchers at Toronto's world-renowned Hospital for Sick Children.
This press release may contain forward-looking statements identified by words such as "expects", "anticipates", "will" and similar expressions, which reflect CellAegis' current expectations regarding future events. The forward-looking statements involve risks and uncertainties that could cause the Company's actual events to differ materially from those projected herein. The forward-looking statements are made as of the date of this press release and CellAegis does not undertake and is not obligated to publicly update such forward looking statements to reflect new information, subsequent events or otherwise, except as required by law.
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